PMLS Virtual Series 2021 – Precision Diagnostics for Precision Medicine Virtual Summit

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May 11, 2021

9:27-9:30am  EST

Welcome & Opening Remarks

Nigel Russell, Founder and President, Precision Medicine Leaders’ Summits, The Journal of Precision Medicine

9:30-10:00am  EST 

CDx Launch Success: From Early Biomarker Development to Commercialization 

Karen Balstrup, MS, MBA, Director, CDx Commercialization, Agilent

An overview of opportunities associated with early biomarker investment for enhancing the demonstration of drug efficacies in target populations

  • An overview of opportunities associated with early biomarker investment for enhancing the demonstration of drug efficacies in target populations
  • How to effectively deploy a drug-Dx co-development strategy as part of your next therapeutic program
  • Establishing successful prelaunch partnerships to ensure candidates are commercially ready and patient access is maximized
  • Actionable insights into leveraging the existing disease landscape to ensure suitable reimbursement is in place for launch
  • Insight on which in-market activities can facilitate the maximum uptake of your co-developed drug and Dx

10:05-10:45am  EST

Keynote – Facing Unknowns and Challenges: COVID-19 Testing in the Vaccine Era

Luis M. Lasalvia, MD, Vice President & Global Medical Officer, Siemens Healthineers

The advent of COVID-19 vaccines requires updated thinking on testing. Dr Lasalvia addresses key challenges and current pressuring unknows impacting testing and diagnostics (testing infrastructure, customizing by specific populations, digital and immunity passports, virus variants, immunity).

10:50-11:50am  EST

Panel Discussion: A Multi-Stakeholder View – Evolving Regulatory and Reimbursement Landscapes for NGS Companion Diagnostics

Co-hosts: Suzanne Belinson, PhD, MPH, Vice President, Commercial Markets, Tempus; Lauren Silvis, JD, Senior Vice President, External Affairs, Tempus

Guests: Michael Kolodziej, MD, Vice President, Chief Innovation Officer, ADVI Health; Omar Perez, PhD, Head Medical Diagnostic Strategy, AstraZeneca

The companion diagnostics landscape has changed dramatically since 1998, after the first CDx approval. This virtual panel discussion will explore the current CDx landscape and how FDA regulation and payer reimbursement is expected to change over the next 5-10 years, through the perspective of payers, regulators, diagnostic companies, and biopharma.

11:55am-1:35pm  EST 

Integrating Personalized Medicine into Healthcare: Progress and a Path Forward

Introductory Stage Setting Presentation:

Featured Speaker: Elissa Quinn, Director, Precision Medicine, Blueprint Medicines

Moderator: Daryl Pritchard, PhD,  Senior Vice President, Personalized Medicine Coalition

Panelists:  Gary Gustavsen, MS,  Partner and Managing Director, Precision Medicine, Health Advances ; Catherine Hajek, MD, Associate Professor of Medicine, USD Sanford School of Medicine and Medical Director, Sanford Imagenetics; Damon Hostin, MS, Lead, Health Systems, Market Access, Illumina; Luca Quagliata, PhD, Vice President and Global Head of Medical Affairs, Clinical NGS and Oncology Division, Thermo Fisher Scientific; Byeong Yoon, PhD, Executive Director, Oncology Global Medical Affairs, Amgen

During this session, experts in precision diagnostics, targeted therapy and healthcare delivery will discuss a first-of-its-kind landscape analysis applying a quantitative multi-factorial framework to assess the clinical adoption of personalized medicine in health care throughout the United States. Based on a survey of a representative sample of 153 health care providers, the analysis , which was commissioned by the Personalized Medicine Coalition, shows that 83 percent of the institutions studied scored a two or higher on the five-point scale used to examine their integration efforts. The study also showed that only 22 percent of the institutions studied scored a four or a five on the personalized medicine integration scale. Panelists will discuss this system-wide but incomplete push to implement personalized medicine in clinical settings, highlighting both the momentum that the field has as well as the limitations associated with the utilization of new precision medicine technologies and practices with extraordinary but understudied potential benefits.

1:40-2:35pm  EST 

The Evolution of Precision Diagnostics in Advancing Oncology Treatment Strategies

Moderator: Steven M. Anderson, PhD, Chief Scientific Officer, Covance; Senior Vice President, LabCorp Drug Development

Panelists: Jeff Conroy, PhD, Chief Scientific Officer, OmniSeq; Taylor Jensen, PhD, Senior Director, Oncology R&D, Labcorp

  • The role of Next Generation Sequencing (NGS) based diagnostics in providing comprehensive treatment options for cancer patients
  • Benefits of broad-panel NGS tumor profiling in bringing more actionable data for better decision-making
  • Role of germ line testing strategies for promoting proactive care and treatment options
  • Key challenges and opportunities in commercializing NGS-based diagnostics

2:35pm  EST 

Closing Remarks

Nigel Russell, Founder and President, Precision Medicine Leaders’ Summits, The Journal of Precision Medicine